Amikacin Sulfate
;)
C22H43N5O13·2H2SO4
781.76
D-Streptamine,O-3-amino-3-deoxy-a-D-glucopyranosyl(1®6)-O-[6-amino-6-deoxy-a-D-glucopyranosyl-(1®4)]-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-,(S)-,sulfate (1:2or 1:1.8)(salt).
O-3-Amino-3-deoxy-a-D-glucopyranosyl-(1®4)-O-[6-amino-6-deoxy-a-D-glucopyranosyl-(1®6)]-N3-(4-amino-L-2-hydroxybutyryl)-2-deoxy-L-streptamine sulfate (1:2or 1:1.8) [39831-55-5].
»Amikacin Sulfate having a molar ratio of amikacin to H2SO4of 1:2contains the equivalent of not less than 674µg and not more than 786µg of amikacin (C22H43N5O13)per mg,calculated on the dried basis;Amikacin Sulfate having a molar ratio of amikacin to H2SO4of 1:1.8contains the equivalent of not less than 691µg and not more than 806µg of amikacin (C22H43N5O13)per mg,calculated on the dried basis.
Packaging and storage—
Preserve in tight containers.
Labeling—
Label it to indicate whether its molar ratio of amikacin to H2SO4is 1:2or 1:1.8.
Specific rotation á781Sñ:
between +76
and +84.
and +84.
Test solution:
20mg per mL,in water.
Crystallinity á695ñ:
meets the requirements.
pHá791ñ:
between 2.0and 4.0(1:2salt),or between 6.0and 7.3(1:1.8salt),in a solution containing 10mg per mL.
Loss on drying á731ñ—
Dry about 100mg,accurately weighed,in vacuum at a pressure not exceeding 5mm of mercury at 110for 3hours:it loses not more than 13.0%of its weight.
for 3hours:it loses not more than 13.0%of its weight.
Residue on ignition á281ñ:
not more than 1.0%,the charred residue being moistened with 2mLof nitric acid and 5drops of sulfuric acid.
Assay—
Mobile phase,System suitability solution,Standard preparation,and Chromatographic system—
Proceed as directed in the Assayunder Amikacin.
Assay preparation—
Transfer an accurately weighed quantity of Amikacin Sulfate,equivalent to about 50mg of amikacin (C22H43N5O13),to a 250-mLvolumetric flask,add about 50mLof water,and swirl to dissolve.Dilute with water to volume,and mix.Transfer 10.0mLof this solution to a 100-mLvolumetric flask,dilute with water to volume,and mix.
Procedure—
Proceed as directed in the Assayunder Amikacin.Calculate the quantity,in µg,of amikacin (C22H43N5O13)in each mg of Amikacin Sulfate taken by the formula:
2500(CE/W)(rU/rS),
in which Wis the weight,in mg,of Amikacin Sulfate taken to prepare the Assay preparation;and the other terms are as defined therein.
Auxiliary Information—
Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 116
Phone Number:1-301-816-8335